ABOUT OZQA
OZQA is a company that specializes in providing comprehensive support for compliance management in the context of FiH clinical trials. Offering practical solutions and guidance to ensure compliance with Good Documentation Practice, Good Clinical Practice, Good Laboratory Practice, and Good Manufacturing Practice.
OZQA provides SOPs with action lists, simple ways to apply and implement, 15 hours of guidance and operation for implementation, QMS setup for FiH inspection, and assistance until all requirements are finalized and signed.
FAQ
You're not alone in navigating QMS requirements for FiH trials – you may find the answers you're looking for here.
What is Quality Management System (QMS)?
QMS is a turnkey solution that provides all the necessary Standard Operating Procedures (SOPs), documentation, and guidance to help you establish a compliant quality framework for your FiH clinical trial. ​ Even if most of your operations are outsourced, you remain responsible as a sponsor. QMS ensures that you have full oversight, control, and compliance with regulatory expectations.
What is included in OZQA’s QMS package?
Our package includes all essential Standard Operating Procedures (SOPs), pre-filled action lists, and 15 hours of expert guidance to support full implementation. The system is built to align with GCP, GDP, GLP, and GMP requirements for FiH clinical trials.
Who is this QMS solution designed for?
OZQA’s QMS solution is specifically designed for sponsors preparing for their first First-in-Human (FiH) clinical trial. It’s ideal for companies with outsourced operations that still carry full regulatory responsibility.
Do we need to have a quality team in place before we start?
No, not necessarily. OZQA supports early-stage companies that may not yet have a full quality function in-house. Our SOPs are simple to apply and tailored for lean teams or solo founders.
How long does it take to implement the QMS?
Implementation typically takes 4–6 weeks, depending on your internal resources and timeline. The included 15 hours of guidance can be spread flexibly to match your pace.
What kind of support do you offer during implementation?
We provide hands-on support including SOP walkthroughs, feedback on execution, regulatory Q&A, and final readiness checks. Our goal is to make you confident and compliant before your FiH inspection.
Can the SOPs be adapted to our specific company setup?
Yes. The SOPs come with editable action lists and templates, allowing you to tailor them to your company's operations while remaining fully compliant.
Will this prepare us for an inspection?
Absolutely. The system is built to help you demonstrate a functioning QMS during a FiH inspection. We help you ensure everything is signed, implemented, and ready for review.
What happens after the 15 hours of support are used?
Additional support can be provided as needed. We offer flexible extensions based on your requirements, whether it's further documentation, training, or audit preparation.